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Active, not recruitingNCT02526082HBSUpdated Aug 18, 2015

Long-term Follow-up of the Helsinki Businessmen Study

An observational study in Quality of Life, Syndromes and Aging, sponsored by Helsinki University Central Hospital. Active, not recruiting. Open to male participants aged 31 Years to 46 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-08-18.

Sponsored by Helsinki University Central Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3,490
Ages
31 Years to 46 Years
Sex
Male
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Study summary

The Helsinki Businessmen Study (HBS) is a clinico-epidemiological longitudinal study started in 1964. It also included a 5-year randomized, controlled multifactorial primary prevention trial of cardiovascular diseases between 1974-1980. The cohort is being actively followed-up through national registers since the 1980, and since 2000 with regular questionnaire surveys. Latest in 2015. Also clinical and laboratory studies have been performed in random subcohorts. Follow-up is ongoing with new hypothesis-generating research questions.

Read the detailed description

The Helsinki Businessmen Study (HBS) was originally a convenient cohort of male executives and businessmen (born 1919-1934, n=3490), who participated in health check-ups between 1964-1973, but since the beginning of 1970s it has developed into a clinico-epidemiological longitudinal study. Primary focus was on the prevention of cardiovascular diseases (CVD), but since 2000 focus has been shifting to geriatrics, and with its long follow-up (up to 50 years) HBS can be seen as a "life-course" study. Traditional CVD risk factors are available from the 1960s and in 1974 participants (available n=3310) were divided in groups according to their clinical status and CVD risk. Two high-risk groups (n=1222) and low-risk group (n=593) participated in a 5-year multifactorial primary prevention study in 1974-1980 (in-trial and post-trial results have been published in 1985 and 1991). The whole original cohort has been followed-up from national registers since 1985 and with regular questionnaire surveys since 2000. Random subcohorts have been studied clinically with laboratory and genetic examinations in 2003 and 2011. The latest questionnaire survey was performed in winter 2015 by which two thirds of the original cohort had died. Follow-up of the cohort is ongoing and new research questions formulated..

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Conditions studied

  • Quality of Life
  • Syndromes
  • Aging
  • Cardiovascular Disease
  • Death

Keywords

  • cardiovascular disease
  • frailty
  • quality of life
  • mortality
  • prevention
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In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's enrollment of 3,490 is above the median of 573 across 1,485 observational studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Helsinki University Central Hospital is the lead sponsor of 299 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
31 Years to 46 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Originally a convenient cohort of male executives and businessmen (born 1919-1934, n=3490), who participated in health check-ups during 1964-1973, but since the beginning of 1970s it has developed into a clinic-epidemiological longitudinal study.

Inclusion criteria

  • Participants of director studies at the Institute of Occupational Health in Helsinki, Finland, between 1964-1973

Exclusion criteria

Exclusion Criteria:

  • Non-participants
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3,490 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Total, observational

    Various cardiovascular risk groups described below

  • High-risk intervention

    Healthy but at high risk in 1974

    Other: Intervention

  • High-risk control

    Healthy but at high risk in 1974

  • Low-risk conrtol

    Healthy and at low risk in 1974

  • Sick control

    Medications or clinical disease in 1974

  • Refused

    Refused or no response in 1974

Interventions

  • OtherIntervention

    Multifactorial intervention with lifestyle changes and drugs as needed

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What researchers measure

Primary outcomes

  1. Total mortality: national registers

    Time frame: change from baseline up to 612 months

Secondary outcomes

  1. Health-related quality of life: questionnaire data

    Time frame: change from baseline up to 612 months

  2. Geriatric syndromes and disability: questionnaires, clinical examinations, registers

    Time frame: change from baseline up to 612 months

  3. Morbidity: self-report, national registers, hospital and autopsy records

    Time frame: change from baseline up to 612 months

  4. Medications: self-report, national registers

    Time frame: change from baseline up to 612 months

  5. Cause-specific mortality: national registers, autopsy records

    Time frame: change from baseline up to 612 months

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Strandberg TE, Salomaa VV, Naukkarinen VA, Vanhanen HT, Sarna SJ, Miettinen TA. Long-term mortality after 5-year multifactorial primary prevention of cardiovascular diseases in middle-aged men. JAMA. 1991 Sep 4;266(9):1225-9. PubMed 1870247 ↗
  • Miettinen TA, Huttunen JK, Naukkarinen V, Strandberg T, Mattila S, Kumlin T, Sarna S. Multifactorial primary prevention of cardiovascular diseases in middle-aged men. Risk factor changes, incidence, and mortality. JAMA. 1985 Oct 18;254(15):2097-102. PubMed 4046137 ↗
  • Strandberg AY, Strandberg TE, Stenholm S, Salomaa VV, Pitkala KH, Tilvis RS. Low midlife blood pressure, survival, comorbidity, and health-related quality of life in old age: the Helsinki Businessmen Study. J Hypertens. 2014 Sep;32(9):1797-804. doi: 10.1097/HJH.0000000000000265. PubMed 25014505 ↗
  • Jyvakorpi SK, Urtamo A, Kivimaki M, Salomaa V, Strandberg TE. Association of midlife body composition with old-age health-related quality of life, mortality, and reaching 90 years of age: a 32-year follow-up of a male cohort. Am J Clin Nutr. 2020 Nov 11;112(5):1287-1294. doi: 10.1093/ajcn/nqaa230. PubMed 32844221 ↗
  • Jyvakorpi SK, Urtamo A, Kivimaki M, Strandberg TE. Associations of protein source, distribution and healthy dietary pattern with appendicular lean mass in oldest-old men: the Helsinki Businessmen Study (HBS). Eur Geriatr Med. 2020 Aug;11(4):699-704. doi: 10.1007/s41999-020-00330-1. Epub 2020 May 22. PubMed 32444996 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 18, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02526082
Lead sponsor
Helsinki University Central Hospital
Responsible party
Timo Strandberg (Professor, Helsinki University Central Hospital) — Principal investigator
First posted
Aug 18, 2015
Start date
Jan 1964
Primary completion
Dec 2040 (estimated)
Completion
Dec 2040 (estimated)
Last update
Aug 18, 2015

Study contacts

Timo E Strandberg, MD
principal investigator · Helsinki University Central Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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